Two New, Competing Diabetes Combination Products Approved by the FDA

The FDA has just approved IDegLira and Lixilan (Sanofi and Novo Nordisk, respectively) for treatment of adults with type 2 Diabetes. Both of these medications contain combinations of long-acting insulins and glucagonlike-peptide 1 receptor agonists (which prevent the body from decreasing insulin amounts present in the body).

LixiLan

LixiLan, by Sanofi, is the first marketed combination of Lantus (insulin glargine) and Lyxumia/Adlyxin (GLP-1 receptor agonist lixisenatide) worldwide. The medication will be produced in a pre-filled pen and will be known as Soliqua 100/33. It will contain a fixed dose of insulin glargine (100 U/mL) and lixisenatide (33 g/mL). The once-daily treatment will cover 5-20 g of the receptor agonist and 15-60 units of the insulin glargine, while utilizing SoloStar technology for medication delivery. SOLIQUA is intended for individuals with type 2 diabetes that is inadequately controlled by lixisenatide alone, or less than 60 units a day of insulin (basal insulin). It will be available in U.S. pharmacies starting January 2017.

IDegLira

IDegLira, by Novo Nordisk, is also a fixed-dose, pre-filled pen medication, that is to be administered in addition to diet and exercise. Its goal is to improve glycemic control for adults with type 2 diabetes that has been inadequately controlled by liraglutide alone (in amounts less than 1.8 mg daily) or with less than 50 units a day of insulin. The medication will be known as Xultophy 100/3.6 and will be a combination of Tresiba (insulin degludec) and Victoza (liraglytide/GLP-1 receptor agonist). The doses of Xultophy will range from 10-50 units and can be taken with or without food, and at the same time each day. The medication is expected to launch in beginning of 2017, before the half-way point of the year.

Interestingly, Xultophy is already utilized in the European Union after being approved by the European Medicines Agency. It is utilized in combination with oral glucose-lowering medications when other methods alone haven’t been sufficient to improve glycemic control. Soliqua has just received initial approval in the EU, and should receive formal approval in the next several months. However, it will be marketed under the name Suliqua in the EU, and will have slightly different dosage combinations. Like its competitor, it will also be utilized with another medication, metformin in this case, when glycemic control isn’t improved by metformin alone, or metformin in conjunction with other oral glucose-lowering meds.

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